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Completed

NCT Number: NCT02222662

Parent-delivered Massage for Children With Autism - Ages 6 to 11

Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute at Western Oregon University (WOU) will be conducting research on the effect of a parent-delivered massage program on measures of autism and general development in children ages 6 to 11 with autism. Families will participate in an initial training, and receive 24 sessions of ongoing support and training from a trained therapist over the first nine months.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Various locations in Portland, Salem, Albany/Corvallis and Eugene

Portland, Salem, Albany, Corvallis, Eugene, Oregon, United States

About this study

Children will be randomly divided into treatment groups and wait-list control groups. The control groups begin treatment five months after the treatment groups begin.

All children will be tested on three occasions in the first year: prior to beginning treatment, and five and twelve months later. Results will be shared with parents at the end of each year. Testers will remain blinded as to which group is currently receiving treatment.

There is no cost to parents for participation in this research study. Families meeting the eligibility criteria will be accepted into the study on a first-come, first-served basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a medical and/or educational diagnosis of autism
  • Be between the age of 6 and 11
  • Parents willing to attend the parent training session and transport the child to treatment sessions with trained staff 20 times in the first five months
  • Parents willing to give the fifteen-minute massage daily
  • Parents willing not to start any new interventions unless medically necessary

Exclusion criteria

  • Taking psychoactive medication or pharmaceutical chelation therapy
  • Additional chronic disability (for example, cerebral palsy or uncontrolled seizures)
  • Receiving more than fifteen hours per week of intensive behavioral treatment for autism (e.g. Applied Behavior Analysis therapy)

Treatment and study plan

Parent massage tx group

Other

The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.

Parent massage wait-list control group

Other

The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.

Primary outcomes

  1. Change in severity of autism

    Time frame: 5 months and one year

    The Childhood Autism Rating Scales will be used to measure this.

Secondary outcomes

  1. Change in developmental skills

    Time frame: 5 months and one year

    The Vineland II will be used to measure this.

Other outcomes

  1. Change in communication skills

    Time frame: 5 months and one year

    The Preschool Language Scale-5 will be used to measure this.

  2. Change in co-morbid symptoms of autism

    Time frame: 5 months and one year

    The Sense and Self-Regulation Checklist will be used to measure this.

  3. Change in degree of parenting stress

    Time frame: 5 months and one year

    The Autism Parenting Stress Index will be used to measure this.

Sponsors and collaborators

Lead sponsor

Western Oregon University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2014
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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